Spectranetics PELA Study Extended

Photonics.comJan 2002
COLORADO SPRINGS, Jan. 16 -- The Spectranetics Corp. said it has FDA approval to continue its peripheral excimer laser angioplasty (PELA) study, without the need to randomize patients. The study extension, PELA III, allows the excimer laser to be used to treat total occlusions at least 10 cm long of the main thigh artery for 120 additional patients at 21 sites. Patients will be enrolled in PELA III during the follow-up and approval phases of the PELA trial, which completed randomized patient enrollment in November, is on track to receive FDA approval in 2003, Spectranetics said.